Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
NCT03790800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2425
Last updated 2025-03-26
Summary
A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).
Conditions
- Stroke, Acute
- Cerebrovascular Disorders
Interventions
- DRUG
-
urapidil
A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists \>150 after 5 minutes.
Sponsors & Collaborators
-
Shanghai East Hospital, China
collaborator UNKNOWN -
First Affiliated Hospital of Chengdu Medical College, China
collaborator UNKNOWN -
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
collaborator UNKNOWN -
The George Institute for Global Health, China
lead OTHER
Principal Investigators
-
Craig Anderson · The George Institute for Global Health, China
-
Lili Song · The George Institute for Global Health, China
-
Gang Li · Shanghai East Hospital, China
-
Jie Yang · Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
-
Yapeng Lin · The First Affliated Hospital of Chengdu Medical College, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-20
- Primary Completion
- 2023-11-23
- Completion
- 2023-11-30
Countries
- China
Study Locations
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